OLANZAPINE NORMON 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Olanzapine Normon 10 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

1. What Olanzapine Normon is and what it is used for
2. What you need to know before you take Olanzapine Normon
3. How to take Olanzapine Normon
4. Possible side effects
5. Storage of Olanzapine Normon
6. Contents of the pack and other information

1. What Olanzapine Normon is and what it is used for

Pharmacotherapeutic group: antipsychotic.

Olanzapine Normon is used to:

• Treat a disease with symptoms such as hearing, seeing or feeling unreal things, mistaken beliefs, unusual suspicion, and tendency to withdraw. People suffering from these diseases may also be depressed, anxious or tense.
• Treat a disorder characterized by symptoms such as feeling euphoric, having excessive energy, a need to sleep much less than usual, talking very quickly with a flight of ideas and, sometimes, considerable irritability. It is also a mood stabilizer that prevents the appearance of extreme variations in mood.

2. What you need to know before you take Olanzapine Normon

Do not takeOlanzapineNormon:

• If you are allergic (hypersensitive) to olanzapine or to any of the other components of olanzapine Normon (listed in section 6). The allergic reaction may manifest as a rash, itching, swelling of the face or lips or difficulty breathing. If this happens to you, tell your doctor;
• If you have previously been diagnosed with narrow-angle glaucoma.
• If you are under 18 years old.

• Warnings and precautions

Talk to your doctor or pharmacist before starting to take Olanzapine Normon.

• Medicines of this type can cause unusual movements, especially in the face or tongue. If this happens to you after taking olanzapine Normon, tell your doctor. Very rarely, medicines of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness and a state of confusion or drowsiness. If this happens to you, stop taking the medication and contact your doctor immediately.
• The use of olanzapine Normon in elderly patients with dementia is not recommended as it may have serious adverse effects.

If you have any of the following diseases, tell your doctor as soon as possible:

• Diabetes
• Heart disease
• Liver or kidney disease
• Parkinson's disease
• Epilepsy
• Prostate problems
• Intestinal blockage (Paralytic ileus)
• Blood disorders
• Stroke or transient cerebral ischemia
• If you suffer from dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or transient cerebral ischemia.
• If you or someone in your family has a history of blood clots, these medications may be associated with the formation of clots.

As a routine precaution, if you are over 65 years old, it would be advisable for your doctor to check your blood pressure.

• Use in children

Patients under 18 years old should not take Olanzapine Normon.

Use of Olanzapine Normon with other medicines

Only use other medicines at the same time as olanzapine Normon if your doctor authorizes it. You may feel a certain sensation of drowsiness if you combine olanzapine Normon with antidepressants or medicines for anxiety or that help you sleep (tranquilizers). Inform your doctor especially if you are taking medication for Parkinson's disease.

You should inform your doctor if you are taking fluvoxamine (antidepressant) or ciprofloxacin (antibiotic), as it may be necessary to modify your dose of Olanzapine Normon.

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medicine.

Taking Olanzapine Normon with food and drinks

The tablets can be taken with or without food, and you should swallow them whole with water.

You should not drink alcohol while taking Olanzapine Normon as the combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy: Tell your doctor as soon as possible if you are pregnant or think you may be pregnant or plan to become pregnant. You should not take this medicine during pregnancy unless your doctor recommends it.

Breastfeeding: You should not take this medicine when you are breastfeeding as small amounts of Olanzapine Normon may pass into breast milk.

Newborns of mothers who have used Olanzapine Normon in the last trimester of pregnancy may present the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding problems. If your newborn presents any of these symptoms, contact your doctor.

Driving and using machines

Olanzapine Normon may cause symptoms such as drowsiness, dizziness or vision changes and decrease your reaction ability. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

Olanzapine Normon contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to use Olanzapine Normon

Follow the administration instructions of Olanzapine Normon indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many Olanzapine Normon tablets you should take and for how long. The normal daily dose ranges from 5 to 20 mg. Consult your doctor if you suffer from symptoms again, but do not stop taking Olanzapine Normon unless your doctor tells you to.

You should take your Olanzapine Normon tablets once a day, following your doctor's instructions.

Try to take the tablets at the same time every day. You can take them with or without food. Olanzapine Normon tablets are for oral administration. You should swallow the tablets whole with water.

Do not interrupt treatment when you feel better. It is very important that you continue taking it while your doctor tells you to.

If you take more Olanzapine Normon than you should

Consult your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount used. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

Patients who have taken more Olanzapine Normon than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face and tongue), and a reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, drowsiness or lethargy, slowing of respiratory rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms.

If you forget to take Olanzapine Normon

Take your tablet as soon as you remember. Do not take a double dose to make up for the forgotten dose.

If you stop taking Olanzapine Normon

If you suddenly stop taking Olanzapine Normon, you may have symptoms such as sweating, insomnia, tremors, anxiety, nausea, or vomiting. Your doctor may suggest gradually reducing the dose before stopping treatment.

Do not interrupt treatment when you feel better. It is very important that you continue taking Olanzapine Normon while your doctor tells you to.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, olanzapine Normon can cause side effects, although not everybody gets them. The side effects observed are classified according to their frequency of presentation:

Very common(at least 1 in 10 patients):

Weight gain.

Drowsiness.

Increased levels of prolactin (hormone that stimulates milk production in the breast).

Common(at least 1 in 100 patients):

Increased levels of a type of white blood cell (eosinophils).

Increased appetite.

High levels of sugar, high levels of triglycerides.

Agitation, parkinsonism, dyskinesia, unusual movements (especially of the face or tongue).

Decreased blood pressure.

Mild gastrointestinal disorders such as constipation and dry mouth.

Asymptomatic and transient increases in liver enzymes (ALT, AST) especially at the start of treatment.

Fatigue, swelling due to fluid retention.

Uncommon(at least 1 in 1,000 patients):

High levels of the enzyme creatine phosphokinase.

Sensitivity to sunlight.

Abnormal heart rhythms, such as slowed heartbeat.

Restless legs syndrome.

Excessive salivation.

Rare(at least 1 in 10,000 patients):

Decreased white blood cells.

Seizures

Skin rashes.

Very rare(less than 1 in 10,000 patients):

Decreased platelets.

Decreased levels of certain white blood cells (neutrophils).

High levels of sugar and/or initial symptoms of worsening diabetes, with acetone in blood and urine or coma.

Increased triglycerides in blood, decreased body temperature.

Cases of Neuroleptic Malignant Syndrome (NMS) have been reported in association with olanzapine.

Parkinsonism, problems with abnormal repetitive movements such as contortions, jerks, and stiffness.

Sweating, insomnia, tremors, anxiety, nausea, or vomiting when stopping treatment.

Pancreatitis.

Liver disease.

Allergic reaction (e.g., anaphylactoid reaction, angioedema, pruritus, or urticaria).

Rhabdomyolysis (increased concentration of the enzyme creatine kinase and myoglobinuria).

Difficulty starting urination.

Prolonged and/or painful erection or difficulty urinating.

Frequency not known:

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS is initially manifested with symptoms similar to those of the flu, with a skin rash on the face that then spreads to other areas, fever, swelling of the lymph nodes, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).

During treatment with olanzapine, elderly patients with dementia may suffer from cerebrovascular effects. In this group of patients, very frequently (at least 1 in 10 patients), walking problems and falls have been observed. Also, frequently (at least 1 in 100 patients), pneumonia, urinary incontinence, extreme fatigue, visual hallucinations, increased body temperature, and skin redness have been observed. Deaths have been reported in this particular group of patients.

Blood clots may form in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), these clots can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, go to your doctor immediately.

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Olanzapine Normon

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiration date that appears on the package after "EXP". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine Normon

The active ingredient is: olanzapine 10 mg.

The other ingredients are: microcrystalline cellulose (E-460), lactose monohydrate, crospovidone, and magnesium stearate.

Appearance of Olanzapine Normon and contents of the pack

Olanzapine Normon 10 mg is presented in the form of cylindrical, biconvex tablets, yellow in color.

Each package contains 28 or 56 tablets.

Other presentations:

Olanzapine Normon 2.5 mg tablets EFG

Olanzapine Normon 5 mg tablets EFG

Olanzapine Normon 7.5 mg tablets EFG

Marketing authorization holder and manufacturer:

Laboratorios Normon, S.A.

Ronda de Valdecarrizo 6,

28760 Tres Cantos, (Madrid)-Spain

Date of the last revision of this leaflet: March 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68838/P_68838.html